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Improving Biopsy Experiences Study for Women

21 Years
Open (Enrolling by invite only)
Imaging Guided Breast Biopsy

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Trial Information

Improving Biopsy Experiences Study for Women

Inclusion Criteria:

- 21 years old or older

- Undergoing imaging guided core needle biopsy

- Mammography or ultrasound Breast Imaging - Reporting and Data System(BI-RADS) final
assessment category 3,4a-c, or 5

- Able to speak and read English

- Able to provide meaningful consent

Exclusion Criteria:

- significant hearing impairment

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Change in Anxiety

Outcome Description:

Anxiety is measured using the State Anxiety Scale of the State Trait Anxiety Inventory. Women complete this self-report measure at baseline (i.e., immediately prior to biopsy in the biopsy clinic) and immediately post-biopsy. Change in anxiety will be measured as change from baseline to post biopsy (i.e., post biopsy anxiety - baseline anxiety.) The expected duration from baseline to post biopsy assessment is expected to be an average of 1.5 hours.

Outcome Time Frame:

Change in anxiety from baseline (i.e., pre biopsy) assessment to post biopsy assessment will be examined. Participants will be followed for the duration of the biopsy, with an expected average of 1.5 hours between assessments.

Safety Issue:


Principal Investigator

Mary Scott Soo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Institutional Review Board

Study ID:




Start Date:

August 2012

Completion Date:

March 2019

Related Keywords:

  • Imaging Guided Breast Biopsy
  • breast biopsy
  • anxiety



Duke Cancer InstituteDurham, North Carolina  27710